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Technological Challenges in the Biopharma Industry

Technological Challenges in the Biopharma Industry

Mr Gaurav Kaushik , MD & CEO, Meteoric Pharmaceuticals

2022-12-28

Even as traditional pharmaceutical behemoths are making a beeline into the biopharma space on an unprecedented scale, it is paving the way for digital innovation across the industry. Given the scale of development within the industry and the push towards digital transformation, biopharma players are now feeling increasing pressure to incorporate new-age technologies into their operations. Across the industry, players have identified digital transformation as a critical strategy to gain a competitive advantage. However, there are teething problems. Fundamental issues such as sourcing funds for digital transformation, formulating a meticulous digital innovation strategy, and finding the right skills and talent to drive innovation are some issues that hinder the fast-track implementation of advanced technology. Despite the challenges, advanced and automated information and data technologies will be the game changers in the years to come for the biopharma industry.

Complex Manufacturing Processes

Biopharma manufacturing entails prolong and complicated processes, which pose many challenges, including quality variation and the imperative for more extensive processing and better drug study. Production of recombinant proteins and molecules consistently at an industrial level is costly and time consuming. Besides, maintaining quality requires controlling and monitoring the manufacturing process and conditions. Molecule modifications drug degradation, including deamidation, hydrolysis, and oxidation potentially affect the efficacy and safety of the drug and thus have to be closely monitored by a way of well defined technology. Moreover, denaturation and aggregation during product production, shipment, and storage deteriorate drug quality. The complexity of advanced treatments such as cell and gene therapies necessitates advanced methodologies and real-time analytics for improved process outcomes. For this, an end-to-end connected bioprocess connecting all systems and equipment digitally is essential to render real-time visibility and analytics across the entire production chain. The challenge is to put intelligent technologies into place to meet the complex
needs of the industry.

Supply Chain Disruptions
Currently, many active pharmaceutical ingredients (APIs) supply chains continue to be fragile, unpredictable, expensive, and inefficient. Unavailability or delay in sourcing critical ingredients delays the time-to-market, which in many cases results in loss of market share to competitors. Agile manufacturing technologies and processes are needed to meet sudden demand spikes and medicine shortages and develop sustainable practices over the long run. However, regulatory policies and quality standards make it equally challenging to replace ingredients with alternatives or to tweak manufacturing processes. Thus, building a resilient and reliable supply of key ingredients through alternative technologies is essential, which may require moving away from traditional, agrarian production methods and leveraging data analytics to source from multiple suppliers.

Technology – the Building Block

Drug development is presently a siloed process – from identifying drug candidates and clinical trials to supply chain management and manufacturing process – with each set of activities being conducted in a separate process. Technology can be the building block to bridge the gap between these operations and release synergies into the process. However, technological implementation is not easy, especially with new therapies such as cell and gene therapies, because of the process complexity involved. Besides, adopting digital technologies across multiple supply chain participants has its challenges. Furthermore, technology adoption percolated to downstream participants without a clear strategy poses difficulties in implementation, resulting in inefficiencies.

In this regard, the key is to build a well-thought digital innovation strategy to bring about a series of transformational shifts within the organization. However, while prominent players have the resources to quickly and seamlessly implement these strategies, small-time players need help to source funds to imbibe digital technologies. As a result, these companies may be compelled to continue to operate with legacy systems. Furthermore, lack of expertise is another cause of concern. While the industry is on the threshold of becoming more automated and digitized than ever, there is a severe lack of technical know-how and skilled manpower to fuel this transformation. Adding to it, the industry is at a nascent stage of transformation; there needs to be more comprehensive technological solutions for the biopharma industry. This results in companies investing in point solutions designed to provide an integrated solution for only some value chain processes. It also curtails the free flow of data across various verticals and different solutions. Moreover, the industry needs to have common protocols and terminologies for sharing data and processes, leading to discrepancies within the organization and across various data sites.

On a concluding note, while it is an exciting time for digital innovation in the biopharma space, effective technology implementation would be crucial to gain a competitive advantage. Therefore, players need to analyze the objectives they wish to achieve, the tools at their disposal, and the solutions available to meet their specific business needs, and accordingly, draft a comprehensive digital innovation strategy to close the gaps, which will enable high-quality and faster delivery of therapies to patients.

Articles about articles | December - 28 - 2022

 

 

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